In this week’s news: Pfizer to outsource more; US FDA updates on plant inspections; EMA waives some fees during pandemic and more…
Pfizer to outsource more to focus on Covid-19 vaccine development
Pfizer will outsource more vaccine manufacturing in order to focus additional resources on development of a SARS-CoV-2 vaccine.
According to Reuters, Pfizer announced the plan last week just days after revealing the vaccine it is working on with BioNTech SE has entered trials in the US.
Pfizer has a network of 200 contractors which includes Catalent Inc and Lonza Group AG. The firm said its partners will “play a bigger role in producing some of its existing medicines,” but did not name specific CDMOs.
The move will primarily effect Pfizer’s vaccines and intravenous drugs.
In addition, Pfizer will hire additional staff at its vaccine manufacturing facilities in order to prepare to ramp up production of the Covid-19 candidate if it is successful.
US FDA outlines expectations for Covid-19 meds
The US FDA has issued guidelines for drug firms and CDMOs making products for the treatment and prevention of Covid-19.
The document covers drugs and treatments, rather than vaccines against SARS-CoV-2 or medicines based on plasma derived antibodies.
The FDA said, “This guidance describes FDA’s current recommendations regarding phase 2 or phase 3 trials for drugs under development to treat or prevent COVID-19.
“This guidance focuses on the population, trial design, efficacy endpoints, safety considerations, and statistical considerations for such clinical trials.”
US FDA updates on drug plant inspections
In other news the US FDA said it will continue to use alternative inspection tools as opposed to site visits for the time being.
It wrote, “In this unprecedented time, we are working hard to help ensure the safety and integrity of the products we all need, while striking an appropriate balance between a scaled back surveillance inspection program and the continuation of providing robust regulatory oversight.”
The FDA is working with the CDC to develop a process that would govern how and where to return to on-site facility surveillance inspections.
Global supply chains under pressure during pandemic
Pharmaceutical supply chains around the world are struggling to cope with Covid-19 related disruption says the Bureau of Investigative Journalism.
The Bureau said drug and API supply chain problems put patients at risk, citing the drug industry’s reliance on too few suppliers as a major concern.
Contributors quizzed by the Bureau suggest drug firms need to build resilience into supply chains by – for example – working with contract manufacturers in several different locations, rather than just hubs in India and China.
EMA waives some fees during pandemic
The EMA will waive GMP inspection fees for drug plants and blood establishments that have undergone remote inspections.
In a press release the Agency said “Reduced fee levels shall be introduced for GMP on-site inspections, in cases where a distant assessment had been conducted for the said site during the period where access to sites for inspections were restricted due to COVID-19 pandemic.”
It added that, “Plasma Master Files inspections are also in the scope of this initiative and will follow the same principle, if applicable.”
Also in the news
ROI-NJ reported Merck is moving its New Jersey operations into a single Rahway headquarters by the end of 2023.
Mylan will make supplies of Gilead’s antiviral remdesivir, which is being tested as a treatment for SARS-CoV-2. See press release.
Gilead has signed a similar accord with Cipla. Under the agreement Cipla will make and distribute the product candidate.
In a related deal, Gilead has signed an agreement with Indian generics firm that will see the later distribute remdesivir in 127 countries worldwide.
The EMA has predicted that a Covid-19 vaccine could be approved in a year. According to a report by RAPS, agency official Marco Cavaleri says the ambition is to have a vaccine approved next spring.
RAPS reported the WHO publication of pandemic operations guidelines relating to inspections and other activities.
Some developments of note in the contracting sector:
Thermo Fisher Scientific has announced plans to double its contract viral vector manufacturing capacity at its facility in n Plainville, Massachusetts.
Ennaid Therapeutics has hired Catalent to help make an oral antiviral treatment that targets Covid-19. The focus will be the development of a capsule formulation of ENU200, an oral antiviral that is being repurposed.
Bluebird Bio has expanded manufacturing agreements with Hitachi Chemical and apceth biopharma.
Thermis has hired ABL Europe – part of the Institute Mérieux group – to make a SARS-COV-2 vaccine candidate for clinical trials. The vaccine is being developed using a measles virus platform technology licensed from the Institut Pasteur in Paris.
Facility design firm Exyte and biomanufacturing technology developer Univercells have partnered to supply modular vaccine production plants.
Univercells – which recently set up a CDMO business – cited the Covid-19 pandemic as the driver for the partnership.